Apparatus and method for delivery, spreading and double-ended fixation of vascular grafts

• • IL 166648 1 Feb. 2005 (01.02.2005)
  • IL 170003 1 Aug. 2005 (01.08.2005)

This application is related to Patent Cooperation Treaty (“PCT”) patent applications PCT/IL2005/000115, filed Feb. 1, 2005, PCT/IL2005/000188, fled Feb. 15, 2005 and PCT/IL2005/001217, filed Nov. 17, 2005, as well as continuation-in-part Israel patent applications IL 166648, filed Feb. 1, 2005, IL 168993, filed Jun. 2, 2005, IL 169210, filed Jun. 16, 2005 and IL 170003, Filed Aug. 1, 2005.

All our earlier patent applications relate to medicine, in particular, to vascular surgery. In all our earlier patent applications, other than IL 166648, filed Feb. 1, 2005, IL 168993, filed Jun. 2, 2005 IL 169210, filed Jun. 16, 2005 and IL 170003, Filed August 1, there are described apparatus and methods for delivery of vascular grafts or stent-grafts inside a blood vessel, substantially the aorta, and for their suturing by one end, which allows to accomplish surgical treatment of such diseases as aorta aneurysm. These methods and apparatus allow to prevent rupture of an aorta aneurysm by locating and suturing inside this aorta a synthetic prosthesis—graft or stent-graft. In patent applications IL 166648, filed Feb. 1, 2005, IL 168993, filed Jun. 2, 2005 and IL 170003, Filed August 1, there are described an apparatus and method for grafts or stent-grafts delivery inside the aorta and their alternate suturing by both ends. All these apparatus and methods have been developed on the basis of prior art and background described in detail in our above mentioned PCT and Israel patent applications.

At the same time, in performing surgical operations for preventing aorta rupture, in particular, of the abdominal aorta section, as well as in performing surgical operations for cleaning blood vessels from calcium patches and other thrombotic deposits using apparatus of “Rotablater” type, it would be appropriate to apply thin-wall or superthin-wall grafts—about 0.1 mm or even less, which might be spread, in particular, over cleaned inner surfaces of blood vessels to prevent formation of new thrombi and deposits. This raises the question of delivering the thin-wall graft inside a blood vessel and successively performing the steps necessary for suturing this graft by one end, its stretching or spreading along the blood vessel lumen, as well as suturing the graft by its second end.

An object of the present invention is to develop a new method and apparatus providing delivery and double-ended fixation of implanted endovascular prosthesis—grafts or stent-grafts, in corresponding blood vessels.

Another object of the present invention is to develop a system of apparatus assembled from a kit of standardized parts (similar to a construction kit for children) which allows to assemble fast an apparatus adapted to the anthropometric conditions of a specific patient and intended for performing a surgical operation to deliver a graft or stent-graft of a specific type and size and double-ended fixation of the latter to the a blood vessel wall.

A third object of the present invention is to develop a new method of endovascular thin wall grafts spreading and double-ended fixation to blood vessel walls.

The subject-matters of the present invention are an apparatus and method for delivery and double-ended fixation of endovascular grafts or stent-grafts to blood vessel walls. The proposed apparatus comprises a tubular body, two expandable working heads with cartridges intended for location of fastener means, with means for securing the ends of an endovascular graft or stent-graft on these heads, as well as a control mechanism containing two control modules joined together via a connecting means.

The apparatus tubular body is configured for positioning within a vessel. This tubular body is rigid in longitudinal direction and flexible in lateral direction, at one its end there are located two working heads, and at its second end—the control mechanism.

The apparatus has two expandable working heads, each with cartridges intended for location of fastener means. These working heads are located at the free end of tubular body and made expandable to keep both ends of a delivered graft or stent-graft in contact with the blood vessel inner surface at the moment of their mutual fixation.

Each of the two working heads contains a cartridge group including substantially eight cartridges which are incorporated in the construction of a corresponding working head. All the cartridges are unified and interchangeable, and each of these cartridges is intended for location at least of two fastener means. All the cartridges are provided with means for retaining therein fastener means, for imparting thereto progressive motion, for forming fastener means during their extension from these cartridges, as well as for storing and feeding standby fastener means. Both working heads are also provided with means for securing thereon the ends of an endovascular graft.